The CardioClip Study (CardioClip)

Hemodynamic-Guided Optimization With the CardioMEMS Device of Patients With Heart Failure and Secondary Mitral Regurgitation Undergoing Mitral Transcatheter Edge-to-Edge Repair With the MitraClip Device

The CardioClip study is exploring the use of a wireless sensor to monitor pressure in the pulmonary artery. This sensor is inserted much like the mTEER procedure, a non-surgical method through a vein in the groin. The investigators want to find out if the sensor, by constantly sending information about heart function, can help improve patient outcomes. This means doctors could adjust medications based on real-time pressure changes detected by the sensor. The results from this study will help pave the way for future trials, asking if using these wireless sensors could benefit people with valve disease and heart failure.

Study Overview

• Status: Recruiting
• Conditions: Mitral Regurgitation; Heart Failure With Reduced Ejection Fraction
• Intervention / Treatment: Device: CardioMEMS

Detailed Description

Patients with heart failure suffer considerably. They experience an increased risk of death and are hospitalized with symptoms of heart failure frequently. Often times, heart failure results in abnormal function of the mitral valve (one of the key valves separating the heart's main pumping chamber - the left ventricle - from the left atrium, which collects oxygenated blood from arteries in the lung). This abnormal function causes the valve to leak - a condition called mitral regurgitation - that perpetuates and can exacerbate heart failure.

Recently, researchers have developed a procedure for patients with mitral regurgitation in the setting of heart failure called mitral transcatheter edge-to-edge repair (mTEER). In this procedure, a "clip" is deployed to grasp the mitral valve leaflet and re-approximate them, thereby reducing the amount of mitral regurgitation. This procedure is performed by accessing one of the large veins in the body and no surgical intervention is required. Patients typically recover within 24 hours and are discharged home without the prolonged recovery periods associated with traditional therapies for mitral regurgitation like open heart surgery and mitral valve repair or replacement. Moreover, the procedure is exceedingly safe, with a very low risk of significant adverse complications.

While mTEER reduces the risk of death and hospitalization for heart failure compared with the standard of care (i.e., medicines geared at improving heart function), many patients still suffer significant adverse events within a five year period. Accordingly, the investigators are interested in identifying strategies to further improve outcomes for patients with heart failure and significant mitral regurgitation. The CardioClip study endeavors to use another technology - a wireless pulmonary artery pressure sensor - that is implanted in a similar fashion to the way mTEER is performed (i.e., percutaneously, without surgery, through one of the veins in the groin), to see whether clinical outcomes can be improved further. The sensor continuously transmits information regarding heart function to clinicians who can optimize medications and their doses according to dynamic changes in pressure noted by the sensor.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kate Dalton, MS, RD, CCRC; Phone Number: (347) 514-3366; Email: keb2114@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
      • Principal Investigator: Nir Uriel, MD
      • Contact: Kate Dalton, MS, RD, CCRC; Email: keb2114@cumc.columbia.edu
      • Principal Investigator: Michael Brener, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Significant (moderate-severe [3+] or severe [4+] secondary MR)
• Left ventricular dysfunction (ejection fraction >20% and <50%)
• New York Heart Association (NYHA) class II-IVa symptoms
• Sign informed consent to participate in the study

Exclusion Criteria:

• Left ventricular (LV) end-systolic dimension 70 mm
• PA systolic pressure 70 mmHg (fixed)
• Mitral valve (MV) orifice area <4.0 cm2
• Commissural MR jet or leaflet anatomy not suitable for mTEER
• Likely to undergo heart transplantation or LV assist device implantation in the next 12 months
• Recurrent (i.e., >1) pulmonary embolism or deep vein thrombosis
• Complex congenital heart disease
• Mechanical right heart valve (tricuspid or pulmonic)
• Cardiac resynchronization therapy implanted within 3 months of enrollment
• Hypersensitivity to aspirin and/or clopidogrel
• History of medication non-adherence

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CardioMems; Participants randomized to this arm will receive hemodynamic-guided GDMT titration with CardioMems.	Device: CardioMEMS; Hemodynamic-guided optimization will be performed using the CardioMEMS CardioClip device.
No Intervention: Usual Care; Participants randomized to this arm will receive usual care involving GDMT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary (OS) score between baseline (pre-mTEER) and 12 months after mTEER.	The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. To facilitate interpretation, all scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life (i.e., higher score indicates a better outcome). The Overall Summary (OS) score is the mean of four subdomain scores, each ranging from 0 to 100. A higher OS score indicates better outcome.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality rate at 12 months	All-cause mortality rate will be calculated at 12 months.	12 months
Rate of HFH at 12 months	Heart failure hospitalization (HFH) rate will be calculated.	12 months
6-minute walk test (6MWT) at 12 months	The 6 minute walk test (6MWT) assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance. The score of the test is the distance a patient walks in 6 minutes at 12 months.	12 months
Change in 6-minute walk test (6MWT) from baseline to 12 months	The 6 minute walk test (6MWT) assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance. The score of the test is the distance a patient walks in 6 minutes. Change of score at baseline and then at 12 months will be calculated.	Baseline and 12 months
Echocardiographic estimates of RV-PA coupling indices	Right ventricular (RV)-pulmonary arterial (PA) (RV-PA) coupling indices will be measured (mm/mmHg) will be measured to determine how the right ventricle and pulmonary circulation interact.	12 months
Device-related (MitraClip) complications at 12 (single-leaflet device detachment, device embolization, endocarditis requiring surgery, mitral stenosis requiring surgery)	MitraClip complications	12 months
Single-leaflet Device Detachments	Device-related MitraClip complications: Total number of single-leaflet device detachment events.	12 months
Device Embolizations (MitraClip)	Device-related MitraClip complications: Total number of device embolizations.	12 months
Endocarditis (Requiring Surgery)	Device-related MitraClip complications: Total number of endocarditis events requiring surgery.	12 months
Mitral Stenosis (Requiring Surgery)	Device-related MitraClip complications: Total number of mitral stenosis events requiring surgery.	12 months
Device- or System-related Failures	Device-related CardioMEMS complications: Total number of device- or system-related failures.	12 months
In Situ Pulmonary Thrombosis	Device-related CardioMEMS complications: Total number of in situ pulmonary thrombosis.	12 months
Device Embolizations (CardioMEMS)	Device-related CardioMEMS complications: Total number of device embolizations	12 months
Number of participants who achieve excellent clinical outcome	An excellent clinical outcome is defined by a) survival, b) KCCQ-OS >60 points, and c) no decline ≥10 points in the KCCQ-OS relative to baseline at 12 months	12 months
KCCQ score - Physical Function domain	The KCCQ-OS evaluates health status from four principal domains: physical function, social function, symptoms, and quality of life. Participants receive a score for 0 to 100 in each domain, with higher scores indicating better health status in that specific domain. The score for each domain will be an individual secondary endpoint.	Baseline, 1 month, 6 months, 12 months post-mTEER
KCCQ score - Social Function domain	The KCCQ-OS evaluates health status from four principal domains: physical function, social function, symptoms, and quality of life. Participants receive a score for 0 to 100 in each domain, with higher scores indicating better health status in that specific domain. The score for each domain will be an individual secondary endpoint.	Baseline, 1 month, 6 months, 12 months post-mTEER
KCCQ score - Symptoms domain	The KCCQ-OS evaluates health status from four principal domains: physical function, social function, symptoms, and quality of life. Participants receive a score for 0 to 100 in each domain, with higher scores indicating better health status in that specific domain. The score for each domain will be an individual secondary endpoint.	Baseline, 1 month, 6 months, 12 months post-mTEER
KCCQ score - Quality of Life domain	The KCCQ-OS evaluates health status from four principal domains: physical function, social function, symptoms, and quality of life. Participants receive a score for 0 to 100 in each domain, with higher scores indicating better health status in that specific domain. The score for each domain will be an individual secondary endpoint.	Baseline, 1 month, 6 months, 12 months post-mTEER
Change in New York Heart Association (NYHA) Classification at 1-, 6-, and 12-months post-mTEER relative to baseline.	The different classes in the NYHA Classification of Heart Failure are: Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort.	Baseline, 1 month, 6 months, 12 months
Win ratio	Win ratio for the hierarchical endpoint of KCCQ improvement ≥10 points at 12 months, NYHA functional class improvement ≥1 class at 12 months, 6MWT improvement ≥30 meters at 12 months, HFH at 12 months, and all-cause mortality at 12 months.	Baseline and 12 months

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Abbott
• Investigators: Principal Investigator: Nir Uriel, MD, Columbia University; Principal Investigator: Michael Brener, MD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: January 27, 2024
• First Submitted That Met QC Criteria: January 27, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Heart failure; Clinical trial; Hemodynamic monitoring; Mitral regurgitation; Reduced ejection fraction; Cardiovascular outcomes; mTEER (mitral transcatheter edge-to-edge repair); CardioMems (implantable pulmonary artery pressure sensor); Guideline-directed medical therapy (GDMT); HF hospitalization (HFH)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Heart Failure; Mitral Valve Insufficiency
• Other Study ID Numbers: AAAU9731

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No